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Continued Treatment Study for Adults with Advanced Cancer Using Pemigatinib

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What is this study about?

This clinical trial is focused on studying the long-term safety and tolerability of a medication called pemigatinib. The study is designed for participants who have advanced forms of cancer and are already receiving treatment with pemigatinib in previous studies. Pemigatinib is a type of medication known as an FGFR inhibitor, which is used to target specific proteins that can contribute to the growth of cancer cells.

The purpose of this study is to provide continued treatment for participants who are benefiting from pemigatinib and do not have access to it outside of a clinical trial. Participants will continue to take pemigatinib in tablet form, which is taken orally. The study will monitor the participants over a period of time to ensure the medication remains safe and well-tolerated.

Throughout the study, participants will have regular check-ups to assess their health and any side effects they may experience. The study aims to gather information on the frequency and nature of any adverse effects, which are unexpected or harmful reactions, to better understand the long-term impact of pemigatinib on patients with advanced cancers. This information will help in determining the overall safety of the medication for future use.

1 enrollment in the study

Upon joining the study, ensure that you have provided written informed consent. This is a formal agreement to participate in the study and must be documented and witnessed.

2 initial assessment

An initial assessment will be conducted to confirm that you are currently enrolled and receiving treatment in a previous study of pemigatinib. It will also be confirmed that you are benefiting from and tolerating the treatment.

3 treatment continuation

Continue taking pemigatinib as prescribed. The medication is available in tablet form and is taken orally. The dosage and frequency will be determined by your healthcare provider based on your specific needs.

4 regular monitoring

Attend scheduled visits for regular monitoring. These visits are important to evaluate the long-term safety and tolerability of pemigatinib. Your healthcare provider will assess your condition and ensure that there is no evidence of disease progression.

5 safety precautions

If you are a male participant, take appropriate precautions to avoid fathering children during the study and for a specified period after the last dose of pemigatinib. If you are a female participant of childbearing potential, ensure a negative pregnancy test before starting the study and take precautions to avoid pregnancy during the study and for a specified period after the last dose.

6 completion of study

The study is estimated to end by December 31, 2024. Continue to follow the study procedures and attend all scheduled visits until the study is completed.

Who Can Join the Study?

  • Must be a male or female participant who is at least 18 years old.
  • Must be currently enrolled and receiving treatment in an Incyte-sponsored clinical study of pemigatinib (a type of medication) either alone or with other treatments.
  • Must be currently benefiting from and tolerating treatment with pemigatinib, as determined by the study doctor.
  • Must have followed the rules and requirements of the previous study, as assessed by the study doctor.
  • Must be willing and able to attend scheduled visits, follow treatment plans, and participate in other study procedures.
  • Must currently have no signs of the disease getting worse, as determined by the study doctor, after treatment with pemigatinib.
  • Must agree to avoid pregnancy or fathering children during the study and for a certain period after the last dose of medication:
    • Men must take precautions to avoid fathering children and must not donate sperm during this time.
    • Women who cannot have children (due to surgery or menopause) are eligible.
    • Women who can have children must have a negative pregnancy test before starting the study and agree to take precautions to avoid pregnancy during the study and for a certain period after the last dose of medication.
  • Must provide written informed consent before joining the study. If unable to write, consent must be formally documented and witnessed by an independent trusted person.

Who Cannot Join the Study?

  • Participants must be at least 18 years old.
  • Participants must be currently receiving treatment with pemigatinib under a parent protocol. Pemigatinib is a medication used to treat certain types of cancer.
  • Participants must be experiencing clinical benefit from pemigatinib treatment.
  • Participants must not have access to pemigatinib outside of a clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Policlinico Le Scotte Siena Italy
Intryb Icuyboxp Frybauavustsh Ovauwatqzxl Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
30.07.2021

Trial locations

Investigated drugs:

Pemigatinib is a medication used in this clinical trial. It is designed to help treat certain types of advanced cancers by targeting specific proteins in the body that are involved in the growth and spread of cancer cells. The goal of using pemigatinib in this study is to evaluate its long-term safety and how well patients can tolerate it over an extended period. This means that researchers are looking to see if patients can continue to use the medication without experiencing severe side effects, and if it remains effective in managing their cancer symptoms.

Investigated diseases:

Cholangiocarcinoma – Cholangiocarcinoma is a type of cancer that forms in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. It typically begins in the cells lining the bile ducts and can occur anywhere along these ducts. The disease progresses as the cancer cells grow and spread, potentially invading nearby tissues and organs. Over time, it can cause blockages in the bile ducts, leading to jaundice and other symptoms. As the cancer advances, it may metastasize to distant parts of the body. The progression of cholangiocarcinoma can vary depending on the location and size of the tumor.

Trial ID:
2023-503406-36-00
Protocol code:
INCB 54828-801
Trial Phase:
Therapeutic exploratory (Phase II)

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